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Sweden’s Calliditas Therapeutics raises SEK210m

Sweden’s Calliditas Therapeutics raises SEK210m

Sweden’s Calliditas Therapeutics (Nasdaq Stockholm: CALTX) has raised SEK210m in a directed share issue of 3,505,291 shares at a price of SEK 60 per share, to domestic and international investors, including the US specialist investor BVF Partners, whcih invested $12m (cSEK112m) in the placing. At the same time, three of its large investors – Stiftelsen Industrifonden, Investinor AS and Bengt Julander – sold 1.5m sharse on the same terms.

Calliditas is focused on the development and potentially the future commercialization of its product candidate Nefecon, a formulation of budesonide that has a time-lag effect to release the drug at a specific part of the gut. This is intended for treatment of patients with the inflammatory renal disease IgA nephropathy (IgAN). Calliditas has so far recruited 200 out of a planned 450 patients for its global Phase III study NefIgArd, and expects a topline data readout expected to occur during the second half of 2020. Calliditas plans to submit the US and EU regulatory applications for accelerated/conditional approval thereafter and intends to self-commercialise in the US.

Last month, Calliditas received a $15m upfront in connection with a deveelopment and commercialisation agreement with Everest Medicines covering Nefecon for iGaN in Greater China and Singapore. The deal has future payments linked to pre-defined development, regulatory and commercialisation milestones up to an additional $106m, including an option worth up to $20m USD for other potential indications, and royalties on sales. The agreement may, depending on the outcome of consultation with the relevant regulatory authorities, lead to the inclusion of Chinese study centers in the ongoing pivotal study, with the result of achieving registration approval for the Chinese market on an accelerated basis.

IgAN is an orphan disease in the US and Europe, but has a higher prevalence in China, where it is the most common primary glomerulonephritis and accounts for about 40% of primary glomerular diseases.

Calliditas has orphan drug designations for Nefecon for the treatment of primary biliary cholangitis and autoimmune hepatitis (AIH) and plans to develop regulatory pathways for these indications.

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